QHACCP危害分析和关键控制点.pptVIP

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QHACCP危害分析和关键控制点.ppt

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QHACCP危害分析和关键控制点

PSH/SQQ Annex I.5 Hazard Analysis and Critical Control Points 危害分析和关键控制点 (HACCP) I.5: Hazard Analysis and Critical Control Points (HACCP) “A systematic, proactive, and preventive method for assuring product quality, reliability, and safety“ WHO: /medicines/library/qsm/trs908/trs908-7.pdf Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals, WHO Technical Report Series No 908, Annex 7, WHO, Geneva, 2003 I.5:危害分析和关键控制点(HACCP) “A systematic, proactive, and preventive method for assuring product quality, reliability, and safety“ WHO: /medicines/library/qsm/trs908/trs908-7.pdf Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals, WHO Technical Report Series No 908, Annex 7, WHO, Geneva, 2003 I.5: Hazard Analysis and Critical Control Points (HACCP) How to perform? 1. Conduct hazard analysis: identify preventive measures for each step of the process 2. Determine critical control points (CCP’s) 3. Establish target levels and critical limit(s) 4. Establish system to monitor the CCP’s 5. Establish corrective actions to be taken, if CCP is out of control 6. Establish verification procedures, that HACCP works effectively 7. Establish documentation of all procedures and keep records I.5:危害分析和关键控制点(HACCP) How to perform? 1. Conduct hazard analysis: identify preventive measures for each step of the process 2. Determine critical control points (CCP’s) 3. Establish target levels and critical limit(s) 4. Establish system to monitor the CCP’s 5. Establish corrective actions to be taken, if CCP is out of control 6. Establish verification procedures, that HACCP works effectively 7. Establish documentation of all procedures and keep records I.5: Hazard Analysis and Critical Control Points (HACCP) Potential Areas of Use(s) To identify and manage risks associated with physical, chemical and biological hazards (including microbiological contamination) Useful when proces